Pre-loaded injector for use with intraocular lens

ABSTRACT

An injector folding and injecting a flexible intraocular lens into the eye of a patient is described. The injector is configured to be loaded with the intraocular lens, and optionally, an aqueous solution, before the injector and lens are sterilized. The injector includes a lens compartment that is configured to prevent leakage of the aqueous fluid from the lens compartment caused by autoclaving/sterilization.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 13/866772, filed Apr. 19, 2013, which claims benefit to U.S.Provisional Application No. 61/356512, filed April 20, 2012. Applicantclaims priority to all of the applications in the chain. Eachapplication in the chain is hereby incorporated herein by reference.

BACKGROUND

The invention relates to a device and a method of injecting a flexibleintraocular lens which is ready to use, that is, ready to be implantedby injections through an incision formed in the wall of a patient's eye.

Flexible intraocular lenses are useful, for example, in a cataractoperation in order to restore sight by a surgical procedure, whichinserts into the eye such intraocular lens, which replaces the naturallens that has become opaque due to the cataract.

Flexible intraocular lenses are often made of hydrophilic material(s)such as, for example, hydrogel, acrygel or acrylic (the latter termdeviating from its normal meaning), which materials are PMMA(polymethylmethacrylate) and/or HEMA (hydroxymethylmethacrylate),hydrated to more than 16%, in particular between 24% and 28%. U.S. Pat.No. 4,787,904 describes various examples of materials that may be usedto produce hydrophilic lenses. These lenses need to be kept in ahydrated state for conservation.

Flexible intraocular lenses can also be made from silicone materials,having a higher refractive index than hydrophilic materials, orhydrophobic acrylic materials with low glass transition temperatures.The latter materials are desirable because they typically have a highrefractive index and lenses made from them unfold more slowly and morecontrollably than silicone lenses. U.S. Pat. No. 7,157,538 describessuch a high refractive index, acrylic material used for makinghydrophobic flexible intraocular lenses.

Flexible intraocular lenses have the advantage of being able to befolded, allowing them to pass through incisions in the eye of smalldimensions. However, the problem arising with these flexible lenses isprecisely that of folding and manipulating them at the moment of thesurgical act. U.S. Pat. No. 4,787,904 proposes to conserve a hydrophiliclens in a folded state in the injection device while being immersed in aconserving solution, the whole assembly being contained in a flexiblepackaging pocket. However, this method may not be used in practice,since a lens which has remained folded for a long period may retain ashape memory of the folded state and therefore does not regain itsunfolded, functional shape after implantation.

As a result, hydrophilic lenses up to now have been conserved flat insterilized rigid containers of conserving solution. At the moment of thesurgical act, the surgeon removes the lens using a pincer, folds it(optionally with the aid of a folding device) or places it in a foldingcartridge or in an injector and injects it into the eye. Thesemanipulations are relatively complex and delicate, increasing the riskof contamination and damage to the lens.

U.S. Pat. No. 6,386,357 discloses a soft intraocular lens-folding devicecomprising a base member with a tapered slide groove portion, and amovable member comprising an elastically bendable pair of legs and acommon base connecting the pair of legs. A soft intraocular lens isintroduced in the lens-receiving portion of the movable member, the lensbeing clamped by wall portions. The lens is folded by moving the movablemember into the groove portion in the base member, forcing the legs ofthe movable member to be drawn near to one another. This document doesnot disclose any means for injecting the folded lens.

U.S. Patent Publication No. 2005182419 discloses an injector for anintraocular lens comprising an injector housing with an intraocular lensdisposed in the housing. The injector further comprises a lens carrier,which, in response to an actuator, engages and moves the lens within anarrowing injection nozzle in order to fold the lens. A plunger is thenused to advance the folded lens and inject it into a patient's eye.Here, folding and injection of the lens cannot be achieved by a single,continuous movement of a plunger, adding complexity to the surgicalprocedure.

What has been needed, and heretofore unavailable, is an injectorconfigured to accept an intraocular lens, the injector also configuredto allow the lens and injector to be sterilized as one unit. In thismanner, the lens is preloaded into the injector, the injector may befilled with a suitable fluid, and then subjected to a sterilizationprocess. The injector should be able to withstand the sterilizationprocess without leaking any fluid from a lens containing portion of theinjector, thus ensuring that the lens stays immersed in the fluid oncethe sterilization process is completed and the injector/lens assembly ispackaged and stored. In this way, the injector/lens assembly is readyfor use by a surgeon without the need to hydrate or rehydrate theintraocular lens, nor load the lens into the injector, prior to surgery.The present invention fulfills these, and other needs.

SUMMARY OF THE INVENTION

In its broadest aspect, the present invention includes an injectorhaving a lens compartment configured to hold an intraocular lens and toprovide for injection of the lens into the eye of a patient. The lenscompartment is configured to hold both the lens and an aqueous fluiddesigned to wet the lens in a sealed condition so that the injector,lens and fluid may be sterilized, preferably by autoclaving.

In another aspect, the present invention includes an injector forfolding and injecting a flexible intraocular lens into the eye of apatient, the injector comprising: an assembly of an injection nozzle, alens compartment that holds an unfolded flexible intraocular lens and isin communication with the injection nozzle, the lens compartment beingconfigured to be filled with a fluid, loaded with an intraocular lens,and then sealed to prevent leakage of the fluid, an injector bodycommunicating with the lens compartment and a plunger that is insertedin the free end of the injector body, and wherein the lens compartmentand injector body comprise a mechanism whereby the lens is first foldedby forces compressing the lens in a non-axial direction in response toan axial movement of the plunger over a first distance and issubsequently ejected from the injector through the injection nozzle inresponse to an axial movement of the plunger over a second distance. Instill another aspect, the lens compartment is integrated in the injectorbody.

In another aspect, the lens compartment includes an upper portion and alower portion, the lower portion having a sealing surface and aplurality of posts extending upwards disposed on the sealing surface,and the upper portion has a sealing surface and a plurality of holesdisposed in the sealing surface of the upper portion configured toreceive the pins disposed on the sealing surface of the lower portion.

In still another aspect, the sealing surface of the upper portionincludes a lip located adjacent thereto, and the sealing surface of thelower portion includes a lip located adjacent thereto, the lips of theupper portion and lower portions configured to be engaged by a clampconfigured to hold the upper and lower portions together in a sealedrelationship. In an additional aspect, the injector further includes anoctagonal finger grip.

In yet another aspect, the invention includes an injector for foldingand injecting into the eye of a patient a deformable intraocular lens,the injector comprising: an injection nozzle assembly; an injector bodyhaving a space for holding an unfolded deformable intraocular lens, theinjector body in communication with the injection nozzle assembly; aflange mounted on the injector body at a position proximal to the spacefor holding the unfolded deformable intraocular lens and the injectionnozzle assembly, the flange having a plurality of seal holes disposedadjacent an outer edge of the flange; a cap configured to be mounted tothe flange and having a plurality of seal posts configured to engage theplurality of seal holes in a one-to-one arrangement, the cap having aninterior space defining a cavity that, when the cap is mounted to theflange, defines a reservoir for holding a fluid to bath the injectionnozzle assembly, the space for holding the unfolded deformableintraocular lens, and an unfolded deformable intraocular space disposedwithin that space; and a flexible clamp configured to engage the flangeand the cap in such a manner as to removably fix the cap to the flangein a fluid tight configuration. In an alternative aspect, the cap has aclear portion through which an intraocular lens contained therein may beviewed.

In another aspect, the invention further comprises an intraocular lensmounted in the space for holding the unfolded deformable intraocularlens of the injector in an undeformed state. In another aspect, anoctagonal finger grip is disposed on the injector body. In still anotheralternative aspect, the space for holding the unfolded deformableintraocular lens is viewable through a window disposed on the injectorbody.

In a further aspect, the invention includes a method for assembling asinjector as described above, comprising: inserting a plunger into theinjector body through an end piece of the injector body; inserting aplunger guide within the injector body; disposing an unfoldedintraocular lens within an internal support cavity of a lens supportwithin the space for holding the unfolded deformable intraocular lens,and mounting the lens support on the plunger guide; assembling theinjector body and the cap by aligning the plurality of seal holes andseal posts in a one to one arrangement; introducing a sufficient volumeof an aqueous solution though an opening in the reservoir to keep thelens wetted; fixing a clamp onto the flange and the cap to hold the caponto the flange in a sealed relationship; packaging the injector in asealable foil packaging; and sterilizing the packaged injector. In onealternative aspect, the aqueous solution is a saline solution.

Other features and advantages of the invention will become apparent fromthe following detailed description, taken in conjunction with theaccompanying drawings, which illustrate, by way of example, the featuresof the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective side view of an improved injector having an endcap, an injector body, a plunger, according to an embodiment of theinvention.

FIG. 2 is a partial view of the injector of FIG. 1 where the end cap hasbeen removed, showing a support guide.

FIG. 3 is another partial view of the injector where end cap, injectorbody, and support guide have been removed, showing a lens support, aplunger guide and a plunger.

FIG. 4 depicts an isolated view of a plunger and a lens support.

FIG. 5 is an isolated view of a lens support with wedge plate, a pair offolding members and an injection nozzle.

FIG. 6 is another isolated view of the lens support with the pair offolding members being pivotally mounted.

FIG. 7A is a perspective view of the lens support mounted within thesupport guide seen from the plunger side, according to an embodiment ofthe invention.

FIG. 7B is a sectional view taken along the line C-C of FIG. 7A.

FIG. 8 is a sectional view illustrating an intraocular lens disposedwithin the lens support, according to an embodiment of the invention.

FIG. 9 illustrates the intraocular lens being completely folded withinthe lens support, according to an embodiment of the invention.

FIG. 10 illustrates a view of the injector of an embodiment of theinvention, viewed from its proximal end showing details modifications tothe proximal end to enhance retention of fluid within the injector.

FIG. 11 is a side view of an end cap of embodiment of FIG. 10.

FIG. 12 is a top view of an embodiment of a clamp used to hold the endcap of FIG. 11 onto the proximal end of the injector of FIG. 10.

FIG. 13 is a partial view of the clamp of FIG. 12 taken along the lineD-D showing the “U shaped” construction of the clamp.

FIG. 14 is a partial view of the clamp of FIG. 12 taken along the lineE-E showing the details of a distal end portion of one side of the claimconfigured to engage a pin of the embodiment of FIG. 11.

FIG. 15 is a top perspective view of an embodiment of an end cap,looking into the end cap from its proximal end.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings in detail, in which like referencenumerals indicate like or corresponding elements among the severalfigures, there is shown in FIG. 1 an embodiment of a preloaded injector.The injector 1 comprises a plunger 2, extending along a longitudinalaxis corresponding to the injection axis A, within a hollow cylindricalinjector body 3. In the example of FIGS. 1 and 2, the injector body 3includes an octagonal shaped finger tab 4 which is intended to provide aholding point to facilitate operation of the plunger 2 during usage ofthe injector to inject a deformable intraocular lens into an eye of apatient. Different configurations of the injector body 3 and finger tab4 are also possible as long as the injector body 3 is provided withmeans against which the fingers of a user can bear.

The injector body 3 is closed at its proximal end by an end piece 6comprising an opening 7 in which the plunger 2 is introduced and guided.The end piece 6 has a sleeve portion 8 arranged to be fixed by snap-fitinto the proximal end of the injector body 3. A first toric joint seal 9(FIG. 3) is accommodated in the end piece 6 in order to fluidly seal theend piece 6 on the injector body 3 and the opening 7 with the plunger 2passing through it. The 9 may be formed of any flexible elastomericmaterial.

At its distal end, or at the end opposite to the end piece 6, theinjector body 3 comprises an oval-shaped flange portion 10 extendingessentially perpendicular to the injection axis A. Flange 10 comprises acollar portion 12 (FIG. 2), extending in the axial direction from part10. Other configurations of the flange 10 are also possible. Forexample, flange 10 can have a circular, an elliptical or a rectangularshape and can be supported on the injector body 3 with support elements(not shown).

In one embodiment of the invention, the injector body 3 comprises afirst portion 16 having a first internal diameter and extending from theflange 10 to a second portion 17 having a second internal diameter thatis smaller than the first internal diameter (FIG. 2). The injector body3 also comprises a third portion 18, having an internal smaller than theone of the second portion 17, and extending between the second portion17 and the end piece 6.

In FIG. 1, the injector 1 comprises an end cap 13 configured to fit overthe collar portion 12 and engage with flange 10 to hold proximal end ofthe injector in a sealed arrangement, allowing for fluid to beintroduced into a cavity of the end cap 13 to form a fluid reservoir andto maintain the fluid within the reservoir formed by the cooperation ofthe end cap and flange 10. A second toric joint seal 11 (FIG. 2) placedaround the outer wall of the collar portion 12 insures the fluidtightness between the end cap 13 and flange 10.

Referring now to FIGS. 10 and 11, details of an embodiment of the flange10 and end cap 13 are shown that improve the ability to maintain fluidwithin the reservoir formed by flange 10 and end cap 13, even when theinjector assembly is sterilized using an autoclave. As one skilled inthe art will understand, when the injector assembly is steam sterilized,pressure may build up within the reservoir that causes fluid to leakfrom the reservoir, either during the sterilization process, orafterwards when the injector is stored. The inventors have observed thatreservoir integrity and fluid retention may be improved by incorporatingseal posts 500 (FIG. 11) disposed around a top edge 505 of the cap 13configured to be received by and engage with seal holes or indents 502disposed on the distal side of flange 10 (FIG. 10). Seal holes 502 mayextend completely through flange 10, or they may be formed only asindents of partial holes disposed on the distal side of flange 10,having a depth sufficient to receive the seal posts 500 such that thedistal side of flange 10 mates with the top edge of cap 13 to form afluid seal.

Referring now to FIG. 12, there is shown a locking clamp 600 configuredto cooperate with flange 10 and the top edge 505 of cap 13. FIG. 13 is asectional view taken along line D-D of FIG. 12 showing the arrangementof one embodiment of locking clamp 600. Clamp 600 is formed to have anapproximate “C” shape that engages edges of flange 10 and top edge 505of the cap 13. To accomplish this, clamp 600 has an upper lip 615 and alower lip 620 connected by a web 610, forming a “U” shaped channel. Thespacing between upper lip 615 and lower lip 620 is configured to acceptan edge of flange 10 and the top edge 505 of cap 13 between the upperand lower lips.

Referring again to FIGS. 11 and 12, cap 13 includes a tab 510 thatincludes one or more posts or pins 515 configured to engage ends 625 ofclamp 600. In one embodiment, each end 625 of clamp 600 is held in placeby a post 515 mounted on a top side of the top edge 505 of cap 13. Thoseskilled in the art will understand that other embodiments are possible,such as an embodiment where the post 515 is replaced by a tab or otherstructure capable of holding end 625 of clamp 600 in place.

FIG. 14 is a partial view taken along line E-E of FIG. 12 that shows howeach of the proximal ends 625 of clamp 600 are configured to engage pins515 of cap 13. As shown, proximal ends 625 are formed in a tab shapethat is defined by partially cutting away lower edge 620 and a portionof web 610. This construction provides a relief that allows the end 625to pass over the top side of flange 10 and engage pin 515. When bothends 625 engage both pins 515, the clamp is securely held in place, andsecurely holds flange 10 and cap 13 together. In this manner, the jointbetween the injector and the cap is made secure and is capable ofwithstanding pressure changes within the cap during sterilization thatcould lead to fluid loss from the reservoir within the cap.

Clamp 600 may be made of any material that is suitable for use with theinjector system such that it is able to withstand autoclaving or methodsof sterilization. Clamp 600 must also be sufficiently flexible to allowplacement of clamp 600 around the flange and cap without breakage. Inthe embodiment shown in FIG. 12, clamp 600 includes hinge 605 formedbetween the two arms of the clamp. Hinge 605 allows the arms of theclamp to be opened for placement about the edges of the flange and cap.Hinge 605 may be an actual hinge arrangement, or the clamp may be formedfrom a material that can be repeatedly articulated, with hinge 605 beingformed from a shape that facilitates such articulation in a “livinghinge” arrangement well known in the art.

Referring again the FIGS. 1-3, the injector 1 also comprises a lenscompartment consisting of a support guide 100 and a lens support 200(FIG. 3). FIG. 2 shows the injector 1 where the end cap 13 has beenremoved from the injector body 3, showing the support guide 100 fixed onthe flange 10. The support guide 100 is an open hollow structure havingside walls defining a tapered internal shape, a narrower, truncatedsupport guide distal end 101, and a wider proximal end 102 having anoval section, or any section conformal with the internal periphery ofthe collar portion 12. The support guide 100 can be mounted and fixed onthe flange 10 by press-fitting its proximal end 102 within the internalperiphery of the 5 collar portion 12.

As shown in FIG. 2, the support guide 100 contains a guiding pin 103fitted in a corresponding indentation 15 in the collar portion 12,insuring a better positioning and fixation of the support guide 100 onthe flange 10. Holes 107 are provided in the support guide 100 in orderto allow for the introduction of a viscoelastic solution within the lenssupport 200 as will be 10 explained below. Holes 107 are accessiblethrough indentations 15 let into the collar portion 12.

Support guide 100 also includes an inspection window 108 disposed on asurface of support guide 100. Inspection window 108 provides for viewingthe positioning and state of an intraocular lens 400 disposed within aninternal support cavity 208 (FIG. 8) when the intraocular lens is loadedinto the injector.

In one embodiment of the invention, the injector body 3 is fabricated inone piece with an injection plastic molding process. The material usedfor the injector body and cap 13 should be sterilizable using variousprocesses, include steam sterilization. The material used for cap 13 maybe opaque or clear. Alternatively, cap 13 may be formed in such a mannerthat a portion of the cap is opaque and a portion of the cap is clear,forming a window, allowing visualization of the portion of the injectorand the lens mounted in the injector, as well as the level of any fluidwithin the reservoir formed by flange 10 and cap 13, that is placedwithin cap 13.

FIG. 3 depicts another partial view of the injector 1 from which theinjector body 3, the end cap 13, and the support guide 100, have beenremoved. In this view, the plunger 2 extending between the end piece 6,with its toric joint seal 9, and the lens support 200, placed underneaththe support guide 100. Also visible in FIG. 3 is a plunger guide 300,disposed 20 within the injector body 3 and extending between theinternal wall of the injector body 3 and the plunger 2. The plungerguide 300 comprises a pair of flexible legs 301 of hollow semi-ovalshape, the legs 301 being connected on the distal side of the plungerguide 300, or on the side of the lens support 200, by a connectingportion 302 integrally formed with the legs 301. The legs 301 each 25comprise a protruding stop piece 303 at their respective free ends.

In FIG. 3, the legs 301 are shown in an unstressed open positionallowing the plunger 2 to move axially within the plunger guide 300. Theplunger guide 300 also comprises two opposite ribs 304, extending alongits whole length. The ribs 304 are guided in corresponding grooves (notshown) provided 30 in the internal wall of the injector body 3, when theplunger guide 300 is inserted within the injector body 3, and used toorient radially and guide axially the plunger guide 300 within theinjector body 3.

FIG. 4 shows a view of the plunger 2 with the lens support 200 disposedat the distal end 22 of the plunger 2. The plunger 2 preferably has anelliptical or ovoid section but can have any other suitable sectionshape such as a circular, square or rectangular section. The plunger 2also comprises clipping means. In the embodiment shown in FIG. 4, theclipping means are two snap hooks 19 that are oppositely disposed on theplunger 2, each at a position corresponding to that one of a stop piece303 of the plunger guide 300.

The lens support 200 according to one embodiment of the invention isrepresented in the perspective views of FIGS. 5 and 6. The lens support200 comprises a pair of parallel wedge plates 201 of tapered shape andconnected, at their narrow extremity, to an injection nozzle 202. Theinjection nozzle 202 is 15 terminated by a nozzle distal end 203destined to be introduced in an incision formed in the wall of apatient's eye during lens replacement surgery. The interior of theinjection nozzle 202 forms a nozzle canal 204. The lens support 200 alsocomprises a folding device for folding the lens 400 in a directionessentially perpendicular to the injector axis in response to axialmovement of the plunger 2, as exemplified by the depictions of FIGS. 8and 9. In the example of FIGS. 5 and 6, the folding device is a pair offolding members 205 being fixed by their distal extremity, which is theextremity on the side of the injection nozzle 202, to the external wallof the injection nozzle 202 with a flexible link 206. The foldingmembers 205 comprise a notch 207 at their distal 25 extremity. The pairof folding members 205 can be pivotally mounted by abutting theirrespective notches 207 against edges of the injection nozzle 202, asshown in FIG. 6. The spacing between the two wedge plates 201 allows thefolding members 205 to pivot within the two plates 201 while beingguided laterally by the plates 201. When the two folding members 205 arein an open position as shown in FIG. 6, the two wedge plates 201 and thefolding members 205 delimit an internal support cavity 208.

The wedges plates 201 also comprise a tail-shaped part 209, extendingalong the plunger 2 and within the plunger guide 300 as shown in FIG. 3.The internal surface of the tail-shaped part 209 forms a groove 210extending along the injection axis A on the internal surface of thewedge plates 201, 5 forming an injection canal that extends the nozzlecanal 204 of the injection nozzle 202. Two ribs 211 extend along theinjection axis A, on the tail-shaped part 209 and the two oppositeexternal surfaces of the wedge plates 201 of the lens support 200.

FIGS. 7A and 7B depict a view of the support guide 100 according to anembodiment of the invention. In FIG. 7A, the support guide 100 is seenfrom the plunger side, and a section view along the line C-C of FIG. 7Ais represented in FIG. 7B. In FIG. 7B, the lens support 200 is alsoshown with pivoted folding members 205.

The support guide 100 comprises two internal lateral sloped ridges 106,formed within the internal surface of the support guide 100 and slopingtoward one another from the support guide proximal end 102 to thesupport guide distal end 101 of the support guide 100. These slopedridges 106 are destined to cooperate with the folding members 205 aswill be explained below.

In the example of FIGS. 7A and 7B, the internal surface of the supportguide 100 also comprises two guiding slots 104 extending along bothsides of the support guide 100, and adapted to guide laterally themovement of the lens support 200 within the support guide 100 along theinjection axis A. The two ribs 211 press against two parallel guidingfaces 105, extending along the injection axis A and oppositely disposedon the internal upper and lower surfaces of the support guide 100, inorder to laterally guide the lens support 200 advancing within thesupport guide 100. Alternatively, the two ribs 211 can also pressagainst two parallel guide ribs (not shown), extending along theinjection axis A and oppositely disposed on the internal upper and lowersurfaces of the support guide 100.

Other configurations of the support guide 100 are also possible. Forexample, the guiding slots 104 can be replaced by a pair of ribs inorder to guide laterally the movement of the lens support 200 within thesupport guide 100 along the injection axis A.

The lens injectors of the present invention and their various parts mayfabricated from different types of plastic materials. For example, theinjector body may be produced from polycarbonate (PC), polyetherimide(PE1) or polysulfone (PSU), the end cap from PC, PE1 or polyamide (PA),the plunger from PC, PE1 or PSU, the support guide from PP, PC,polybutylene-terephtalate (PBT) or polyoxymethylene (PaM), the lenssupport from PaM, PP, BC, PA, PE1 or polyethylene-terephtalate (PET),the plunger guide from PA, PBT or polypropylene, the plug from siliconeor a vulcanized thermoplastic material, and the toric joints fromsilicone.

When assembling the injector 1, the end piece 6 and the toric joint seal9 are first disposed on the proximal end of the plunger 2. Here, theplunger 2 is inserted into the end piece 6 through the opening 7. Theplunger 2 is then inserted into the injector body 3. The two snap hooks19 of the plunger 2 are arranged such as to be able to pass through thethird portion 18 of the injector body 3, and abut against the distal endof portion 18 once the hooks 19 have passed this portion 18, preventingthe plunger 2 from moving backward. Preferably, the end piece 6 is notyet clipped on the proximal end of the injector body 3.

In a preferred embodiment of the injector of the invention, a flexible25 plug 20 is subsequently mounted on the distal end of plunger 22. Theplug 20 is preferably made from a soft and flexible material, in orderto avoid scratching of the lens 400 during the injection operation.Here, the distal end of the plunger 2 can comprise a forked distal end22, as shown in FIG. 4, allowing the flexible plug 20 to extend at leastpartially in between the two teeth of the distal end 22. Otherconfigurations of the distal end 22, that abuts the plug 20, are alsopossible. It is noted that plug 20 may be added to the plunger end 22 ata later stage, but prior to the mounting of the lens support 200 on theplunger guide 300.

The plunger guide 300 is next mounted within the injector body 3. Thetwo opposite ribs 304 of the plunger guide 300 are guided within thecorresponding grooves of the injector body 3 allowing the plunger guide300 to be introduced into the desired angular position within theinjector body 3. When the plunger guide 300 reaches its full rearposition, it is forced into its closed position, the clipping means ofthe plunger 2, here the two snap hooks 19, are able to engage on thedistal edge of the stop pieces 303, reversibly connecting the plungerguide 300 and the plunger 2.

The respective internal diameters of the portions 16, 17, 18 are such asto allow the plunger guide 300 to be introduced within the first andsecond portions but not within the third portion 18. The plunger guide300 introduced within the injector body 3 from the flange 10 side thusabuts against the end of 15 the second portion 17, adjacent to the thirdportion 18. In this initial position, the plunger guide 300 extendsalong the first and second portions 16, 17. The internal diameter of thesecond portion 17 is such as to force the two opposite stop pieces 303of the legs 301 to come in contact with the two snap hooks 19, theplunger guide 300 being thus in a closed position. When, in response toa forward movement of the plunger, the plunger guide is advanced out ofthe second portion 17 and into the first portion 16, the plunger guide300 is able to regain its unstressed open position.

Other configurations of the injector body 3 are also possible, as longas they provide a configuration that enables the plunger guide 300 to beeither in a closed position or in an unstressed open position, dependingon the axial position of the plunger guide 300 within the injector body3. For example, the injector body 3 can have a uniform internal diameteralong its whole length but comprise internal ribs distributed around itsinternal wall, the ribs having a height that varies between sectionsalong the injector body 3.

An intraocular lens 400 is then disposed unfolded between the two wedgeplates 201, within the internal support cavity 208 (FIGS. 6 and 8).Preferably, the lens 400 is disposed within the internal support cavity208 with the two haptics 401 of the lens being oriented along theinjection axis A, as shown in FIG. 8.

The lens support 200 containing the lens 400 is then mounted on theplunger guide 300 by inserting the tail-shaped part 209 within theconnecting portion 302 of the plunger guide 300 (FIGS. 3 and 6). In thisposition, the two folding members 205 are prevented from pivoting on theintraocular lens 400 by abutting against two protrusions 23 located onthe flange 10 of the injector body 3 (FIG. 8). Also shown in FIG. 8 aretwo protruding members 21 arranged to maintain the unfolded lens 400within the lens support 200 in its unfolded orientation as describedabove, until the lens 400 is folded and ejected. The protruding members21 do not prevent the pivoting of the two folding members 205.

The support guide 100 is then fixed on flange 10 of the injector body 3and the end cap 13 is placed over the injector, aligning seal holes 502(FIG. 10) with seal posts or pins 500 (FIG. 11) and fastened to flange10 using clamp 600 (FIG. 12) after placing the second toric joint seal11 around the external periphery of the collar portion 12 (FIGS. 1 and2). The second toric joint seal 11 could also be placed at any otherinjector assembly steps, before the step of mating end cap 13 with theflange 10, described below.

In the case of a flexible hydrophilic intraocular lens, the end cap 13and the injector body 3 are filled with an aqueous solution or fluidsuch as a saline solution, distilled water, or any other aqueoussolution adequate for keeping the intraocular lens 400 wet. The aqueoussolution may be introduced through filling openings, in the proximal endof the injector body 3 by means of a syringe.

The aqueous solution fills at least partly the volume enclosed by theend cap 13, lens support 200 and injector body 3. In the case a flexiblehydrophobic intraocular lens is used, there is no need for a bathingsolution or fluid such as saline and the step of filling the injectorbody 3 and the end cap 13 with an aqueous 30 solution may be omitted.

When the end cap 13 is fixed on the injector body 3, the lens support200 abuts against the end cap 13 and the plunger 2 cannot be depressed.

In a preferred embodiment of the invention shown in see FIG. 15, end cap13 comprises a central hollow tube 24 extending along the injection axisA toward the injector body 3. When the end cap 13 is fixed on theinjector body 3, the distal end 215 of both opposite support ribs 211 ofthe lens support 200 abuts against the proximal end 25 of the centraltube 24. In this configuration, the plunger 2 cannot be moved backwarddue to the snap hooks 19 abutting against the distal end of portion 18,as described above. Consequently, any false manipulation of the plunger2 prior to the injection operation is avoided.

After fixing the end cap 13, the toric joint seal 9 is placed on agroove 26 on the proximal end of the injector body 3 (FIG. 9) and theend piece 6 is clipped on said proximal end, making the interior of theinjector body sealed. The injector 1 is then ready to be packaged into asealable flexible packaging (not)) such as a sleeve, pouch or blister,or any other packaging. After the packaging is sealed, the packagedinjector 1 is subjected to sterilization. A preferred method ofsterilization is steam sterilization (autoclaving). In one alternativeembodiment, the sleeve or pouch may be formed from a suitable foilmaterial.

Prior to the injection operation, the injector is separated from itspackaging, clamp 600 is removed and the end cap 13 is separated andremoved from the flange 10, causing the aqueous solution to drain fromthe injector body 3 and the lens support 200. In order to keep the lens400 and lens support 200 lubricated during the injection operation, aviscoelastic solution such as a solution containing hyaluronic acid,chondroitin sulfate or a cellulose derivative such ashydroxypropylmethylcellulose (HPMC) can be introduced within theinternal support cavity 208 through holes 212 provided in the wedgeplates 205 and the corresponding holes 107 of the support guide 100, forexample, by using a syringe. Alternatively or in addition, theviscoelastic solution can also be introduced through the nozzle distalend 203 of the injection nozzle 202. The holes 107 and 212, and thenozzle distal end 203 also increase the fluidic communication within theend cap 13, facilitating the penetration of aqueous wetting solutioninto the lens support 200.

During an injection operation, the plunger 2 is depressed causing theplunger guide 300 to move forward over a first distance, advancing thelens support 200 within the support guide 100 along the injection axisA. During the advance of the lens support 200, the sloped ridges 106 ofthe support guide 100 force the pair of folding members 205 to pivottoward the injection axis A, drawing them near to one another until theybecome essentially parallel to the injection axis A, transforming theinternal support cavity 208 into an injection canal 213 that extendsalong the folded folding members 205 and into the nozzle canal 204 ofthe injection nozzle 202. The lens support 200 advances in the supportguide 100 until it abuts against the support guide 100 and cannotadvance further.

Alternatively, the advance of the lens support 200 within the supportguide 100, the folding members 205 of the lens support 200 may interactwith the internal tapered side walls, forcing the folding members 205 topivot inward and fold the intraocular lens in a direction essentiallyperpendicular to the injection axis A.

The above operation causes the intraocular lens 400 to fold, the lens400 being folded or rolled in a direction essentially perpendicular tothe injection axis A as shown in FIG. 7B, when completely folded.Consequently, the folded lens 400 is ready to be advanced axially intothe nozzle canal 204.

In one embodiment of the invention, each folding member 205 comprises aprotruding element 214. When the lens support 200 advances within thesupport guide 100, the sloped ridges 106 press against the protrudingelements 214, and pivots the pair of folding members 205 toward theinjection axis A, as described above. The protruding elements 214 canadvantageously enhance the angular distance the folding members 205 willtravel within the lens support 200 during the forward motion of the lenssupport within the support guide 100. Moreover, the use of protrudingelements 214 can also reduce the friction during the advancement of thelens support 200 within the support guide 100, compared to a contactmade along the whole folding member 205.

When the plunger 2 has moved over the first distance and the lenssupport 200 reached its abutting position within the support guide 100,the plunger guide 300 has moved completely outside the second portion 17and extends only within the first portion 16 of the injector body 3 andwithin the support guide 100. It is noted that once plunger guide 300has moved outside of second portion 17, it cannot be returned to itsinitial position within portion 17, thereby preventing an unfolding ofthe folded lens as a consequence of an accidental retraction of plunger2. The diameter of the first portion 16 is large enough to allow the twolegs 301 of the plunger guide 300 to regain their unstressed position,in which the two legs 301 are slightly bent apart, enabling the plungerguide 300 to be detached from the plunger 2, allowing the plunger 2 tomove freely within the plunger guide 300 and advance within it.

When operator pressure continues to be applied, the plunger 2 and plug20 advance over a second distance and propel the folded lens 400 alongthe injection canal 213, and outside the nozzle distal end 203, enablingthe lens 400 to be injected into the patient's eye (FIG. 9). Theflexible plug 20 is able to follow conformably the varying dimensions ofthe internal support cavity 208 formed by the two folding members 205and the nozzle canal 204, avoiding the necessity of requiring accuratedimensions for the different parts forming the compressed support cavity208 and the nozzle canal 204.

In an exemplary embodiment of the invention, the lens support 200 isable to advance in the support guide 100 over a distance of about 15 mm,this distance corresponding to the length of the second portion 17 ofthe injector body 3. Here, the total length formed by the first andsecond portions 16, 17 corresponds essentially to the length of theplunger guide 300.

In one embodiment of the invention, the lens support 200, comprising thetwo wedge plates 201, the injection nozzle 202, the two folding, members205 and links 206, is fabricated in one piece by an injection plasticmolding process.

While several particular forms of the invention have been illustratedand described, it will be apparent that various modifications can bemade without departing from the spirit and scope of the invention.

1-5. (canceled)
 6. A method for assembling the injector of claim 1, comprising: inserting a plunger into the injector body through an end piece of the injector body; inserting a plunger guide within the injector body; disposing an unfolded intraocular lens within an internal support cavity of a lens support within the space for holding the unfolded deformable intraocular lens, and mounting the lens support on the plunger guide; assembling the injector body and the cap by aligning the plurality of seal holes and seal posts in a one to one arrangement; introducing a sufficient volume of an aqueous solution though an opening in the reservoir to keep the lens wetted; fixing a clamp onto the flange and the cap to hold the cap onto the flange in a sealed relationship; packaging the injector in a sealable foil packaging; and sterilizing the packaged injector.
 7. The method of claim 6, wherein the aqueous solution is a saline solution. 